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https://hdl.handle.net/1822/67475
Título: | Risk estimates for persistent high-risk human papillomavirus infections as surrogate endpoints of progressive cervical disease critically depend on reference category: analysis of the combined prospective cohort of the New Independent States of the Former Soviet Union and Latin American Screening Studies |
Autor(es): | Syrjänen, K. Shabalova, I. Naud, P. Kozachenko, V. Derchain, S. Zakharchenko, S. Roteli-Martins, C. Nerovjna, R. Longatto, Adhemar Kljukina, L. Tatti, S. Branovskaja, M. Hammes, L. S. Branca, M. Grunjberga, V. Eržen, M. Juschenko, A. Costa, S. Sarian, L. Podistov, J. Syrjäen, S. Maeda, M. Y. S. NIS LAMS Study Research Groups |
Palavras-chave: | HPV persistence Disease progression Prospective follow-up Surrogate endpoint Reference category NIS Cohort LAMS Study New-generation HPV vaccines |
Data: | Jun-2011 |
Editora: | SAGE Publications |
Revista: | International Journal of STD & AIDS |
Citação: | Syrjänen, K., Shabalova, I., Naud, P., Kozachenko, V., Derchain, S., et. al.(2011). Risk estimates for persistent high-risk human papillomavirus infections as surrogate endpoints of progressive cervical disease critically depend on reference category: analysis of the combined prospective cohort of the New Independent States of the Former Soviet Union and Latin American Screening Studies. International journal of STD & AIDS, 22(6), 315-323 |
Resumo(s): | To make feasible future clinical trials with new-generation human papillomavirus (HPV) vaccines, novel virological surrogate endpoints of progressive disease have been proposed, including high-risk HPV (HR-HPV) persistence for six months (6M+) or 12 months (12M+). The risk estimates (relative risks [RRs]) of these ‘virological endpoints’ are influenced by several variables, not yet validated adequately. We compared the impact of three referent groups: (i) HPV-negative, (ii) HPV-transient, (iii) HPV-mixed outcome on the risk estimates for 6M+ or 12M+ HR-HPV persistence as predictors of progressive disease. Generalized estimating equation models were used to estimate the strength of 6M+ and 12M+ HR-HPV persistence with disease progression to squamous intraepithelial lesions (SILs), cervical intraepithelial neoplasia (CIN) grade 1 +, CIN2+, CIN/SIL endpoints, comparing three optional reference categories (i)-(iii) in a prospective sub-cohort of 1865 women from the combined New Independent States of the Former Soviet Union (NIS) and Latin American Screening (LAMS) studies cohort (n = 15,301). The RRs of these viral endpoints as predictors of progressive disease are affected by the length of viral persistence (6M+ or 12M+) and the surrogate endpoint (SIL, CIN1, CIN2, CIN/SIL). Most dramatic is the effect of the referent group used in risk estimates, with the HPV-negative referent group giving the highest and most consistent RRs for both 6M+ and 12M+ viral persistence, irrespective of which surrogate is used. In addition to deciding on whether to use 6M+ or 12M+ persistence criteria, and cytological, histological or combined surrogate endpoints, one should adopt the HPV-negative referent group as the gold standard in all future studies using viral persistence as the surrogate endpoint of progressive disease. |
Tipo: | Artigo |
URI: | https://hdl.handle.net/1822/67475 |
DOI: | 10.1258/ijsa.2009.009365 |
ISSN: | 0956-4624 |
e-ISSN: | 1758-1052 |
Versão da editora: | https://journals.sagepub.com/doi/abs/10.1258/ijsa.2009.009365 |
Arbitragem científica: | yes |
Acesso: | Acesso restrito autor |
Aparece nas coleções: | ICVS - Artigos em revistas internacionais / Papers in international journals |
Ficheiros deste registo:
Ficheiro | Descrição | Tamanho | Formato | |
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syrjanen2011.pdf Acesso restrito! | 158,4 kB | Adobe PDF | Ver/Abrir |